K243966
- 510(k) number
- K243966
- Device name
- FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
- Applicant
- Faceheart Corp. KY
- Product code
- BZQ — Monitor, Breathing Frequency
- Decision date
- 2025-04-09
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243966.pdf
Official FDA record: K243966
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.